Label: CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet

  • NDC Code(s): 58602-444-09, 58602-444-17, 58602-444-21, 58602-444-41, view more
    58602-444-47, 58602-445-01, 58602-445-09, 58602-445-15, 58602-445-17, 58602-445-19, 58602-445-21, 58602-445-38, 58602-445-40, 58602-445-41, 58602-445-47, 58602-445-54, 58602-445-60, 58602-445-65, 58602-445-94, 58602-812-04, 58602-812-09, 58602-812-17, 58602-812-23, 58602-812-39, 58602-812-41, 58602-812-83, 58602-812-99
  • Packager: Aurohealth LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 19, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION


    Drug Facts

  • Active ingredient (in each tablet)


    For 5 mg:

    Cetirizine hydrochloride USP 5 mg

    For 10 mg:

    Cetirizine hydrochloride USP 10 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:


    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • Warnings

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

  • Ask a doctor before use if you have

    liver or kidney disease. Your doctor should determine if you need a different dose.

  • Ask a doctor or pharmacist before use if you are

    taking tranquilizers or sedatives.

  • When using this product

    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
  • Stop use and ask a doctor if

    an allergic reaction to this product occurs. Seek medical help right away.

  • If pregnant or breast-feeding:

    • If breast-feeding: not recommended
    • if pregnant: ask a health professional before use.
  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. [1-800-222-1222]

  • Directions


    For 5 mg:

    adults and children 6 years and over
    1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
    adults 65 years and over
    1 tablet once a day; do not take more than 1 tablet in 24 hours
    children under 6 years of age
    ask a doctor
    consumers with liver or kidney disease
    ask a doctor

    For 10 mg:

    adults and children 6 years and over
    one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.  A 5 mg product may be appropriate for less severe symptoms.
    adults 65 years and over
    ask a doctor
    children under 6 years of age
    ask a doctor
    consumers with liver or kidney disease
    ask a doctor
  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING.
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

  • Questions?


    call 1-855-274-4122

    Distributed by:
    AUROHEALTH LLC
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

    Made in India

    Code: TS/DRUGS/19/1993

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

    AUROHEALTH
    Original Prescription Strength             NDC 58602-444-09
    Cetirizine
    Hydrochloride
    Tablets USP 5 mg
    Antihistamine                                       Allergy
    Indoor & Outdoor Allergies

    24 hour
    Relief of

    • Sneezing                                      
    • Runny Nose                            
    • Itchy, Watery Eyes                       
    • Itchy Throat or Nose

    30
    Tablets
    5 mg each

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg (30's Tablet Container Carton Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label)

    AUROHEALTH
    NDC 58602-444-21
    Original Prescription Strength
    Cetirizine
    Hydrochloride
    Tablets USP
    5 mg
    Antihistamine
    Allergy
    Indoor & Outdoor Allergies

    24 hour
    Relief of

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    100 (10 x 10) Unit-dose Tablets

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg (10 x 10 Blister Carton Label)


  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

    AUROHEALTH
    NDC 58602-445-09
    *Compare to the active
    ingredient of Zyrtec®

    Allergy Relief
    Cetirizine Hydrochloride Tablets USP 10 mg
    Antihistamine
    Original Prescription Strength

    Indoor & Outdoor Allergies
    24 Hour Relief of :

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    30 Tablets
    10 mg each

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30's Tablet Container Carton Label)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

    AUROHEALTH
    NDC 58602-445-21
    *Compare to the active
    ingredient of Zyrtec®

    Allergy Relief
    Cetirizine Hydrochloride Tablets USP 10 mg
    Antihistamine
    Original Prescription Strength

    Indoor & Outdoor Allergies
    24 Hour Relief of :

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    100 (10x10) Tablets
    10 mg each

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (10 x 10 Blister Carton Label)

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE (ALLERGY) 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-444
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White to Off-white) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code X;35
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-444-091 in 1 CARTON08/05/2015
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-444-171 in 1 CARTON08/05/2015
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-444-4775 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
    4NDC:58602-444-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
    5NDC:58602-444-2110 in 1 CARTON08/05/2015
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09076008/05/2015
    CETIRIZINE HYDROCHLORIDE (ALLERGY) 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-445
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White to Off-white) Scoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code X;36
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-445-091 in 1 CARTON08/05/2015
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-445-171 in 1 CARTON08/05/2015
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-445-4775 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
    4NDC:58602-445-151 in 1 CARTON08/05/2015
    460 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-445-191 in 1 CARTON08/05/2015
    590 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:58602-445-941 in 1 CARTON08/05/2015
    6100 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:58602-445-381 in 1 CARTON08/05/2015
    7300 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:58602-445-40500 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
    9NDC:58602-445-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
    10NDC:58602-445-2110 in 1 CARTON08/05/2015
    1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    11NDC:58602-445-011 in 1 CARTON08/05/2015
    1114 in 1 BLISTER PACK; Type 0: Not a Combination Product
    12NDC:58602-445-601 in 1 CARTON08/05/2015
    125 in 1 BLISTER PACK; Type 0: Not a Combination Product
    13NDC:58602-445-541 in 1 CARTON08/05/2015
    1370 in 1 BOTTLE; Type 0: Not a Combination Product
    14NDC:58602-445-652 in 1 CARTON11/21/2019
    147 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09076008/05/2015
    CETIRIZINE HYDROCHLORIDE (ALLERGY) 
    cetirizine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-812
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White to Off-white) Score2 pieces
    ShapeRECTANGLE (off-rectangular) Size9mm
    FlavorImprint Code X;2;0
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-812-091 in 1 CARTON08/05/2015
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:58602-812-171 in 1 CARTON08/05/2015
    245 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:58602-812-9975 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product08/05/2015
    4NDC:58602-812-231 in 1 CARTON08/05/2015
    4120 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:58602-812-391 in 1 CARTON08/05/2015
    5365 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:58602-812-411000 in 1 BOTTLE; Type 0: Not a Combination Product08/05/2015
    7NDC:58602-812-0410 in 1 CARTON08/05/2015
    7NDC:58602-812-8310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09076008/05/2015
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917642ANALYSIS(58602-444, 58602-445, 58602-812) , MANUFACTURE(58602-444, 58602-445, 58602-812)